Zilver 635 G36238Recalls & reported problems
Cook Ireland Ltd · Zilver 635 Biliary Stent · Class 2 · Implant
All models of Zilver 635 (55)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10827002362380), received between Jun 22, 2022 and Jun 22, 2022 — classified as 1 injury.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Most reported problems
Device problems
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryJun 22, 2022Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method
AS REPORTED TO CUSTOMER RELATIONS VIA COMPLAINT FORM "EXPIRED PRODUCT IMPLANTED". DID ANY SECTION OF THE DEVICE REMAIN INSIDE THE PATIENT¿S BODY? - YES. PLEASE DESCRIBE THE OBJECT AND HOW IT WAS RETRIEVED: DID THE PATIENT EXPERIENCE A DELAY OR REQUIRE ANY ADDITIONAL PROCEDURE DUE TO THIS OCCURRENCE? NO. PLEASE SPECIFY DELAY OR ANY ADDITIONAL PROCEDURE(S) AND PROVIDE DETAILS: HAS THE COMPLAINANT REPORTED ANY ADVERSE EFFECTS ON THE PATIENT DUE TO THIS OCCURRENCE? HAS THE COMPLAINANT REPORTED THAT THE PRODUCT CAUSED OR CONTRIBUTED TO THE ADVERSE EFFECTS? PLEASE SPECIFY ADVERSE EFFECTS AND PROVIDE DETAILS. - EXPIRED PRODUCT IMPLANTED ARE IMAGES OF THE DEVICE OR PROCEDURE AVAILABLE? N/A, YES, NO. WAS THIS A PRIMARY PROCEDURE OR A RECURRENT PROCEDURE? N/A, PRIMARY, RECURRENT, IF THIS WAS A RECURRENT PROCEDURE, WHAT PROCEDURE HAD BEEN PERFORMED PREVIOUSLY? PTCD, ERCP, OTHER. IF OTHER, PLEASE SPECIFY. WAS A STENT PREVIOUSLY PLACED DURING PREVIOUS PROCEDURES? N/A, YES, NO IF THERE WAS A STENT ALREADY IN PLACE, WAS THE COMPLAINT STENT PLACED IN THE STENT THAT WAS ALREADY IN SITU? N/A, YES, NO. WAS THE DEVICE USED PERCUTANEOUSLY? N/A, YES, NO. WHERE ON THE PATIENT WAS THE PERCUTANEOUS ACCESS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14775197 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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